Correction of retinal ischemia/reperfusion by 3-(1H-benzimidazol-2-il)-1,2,2-trimethyl cyclopentancarbonic acid in experiment

Results of ocular fundus studies revealed the most pronounced protective effects of 3-(1Hbenzimidazol-2-il)-1,2,2-trimethyl cyclopentancarbonic acid in a dose 50 mg/kg on the model of retinal ischemiareperfusion in Wistar rats, which is reflected in the restoration of the optic disc. Correction of retinal ischemiareperfusion by 3-(1H-benzimidazol-2-il)-1,2,2-trimethyl cyclopentancarbonic acid in a dose 50 mg/kg leads to higher values of the coefficient b/a of electroretinography after 72 hours of reperfusion compared to the group with pathology correction by the same drug in a dose 10 mg/kg, which indicates the restoration of the electrophysiological state of the retin

Dynamics of findings of non-specific resistance in the mouth cavity in children with lesions of the mucous membrane epithelium of the mouth cavity against acute lymphoblastic leukemia in the treatment process.

There was con­ducted study of dynamics of findings of non-specific resistance in the mouth cavity in children with lesions of the mucous membrane epithelium of the mouth cavity against acute lymphoblastic leukemia  in the treatment process by authors-developed methods. It is known that in children with leukemia immunodeficiency states develop immunological disorders resulted from treatment with cytotoxic drugs. Moreover, not only general, but also the local immunity of the mouth cavity suffers, which is accompanied by development of infectious processes in the tissues that perform the barrier function, which include mucous membrane epithelium of the mouth cavity. A key role in the system of antimicrobial protection of the mouth cavity is performed by mucolytic enzyme lisocyme and α-defensins (HNP 1-3). 76 children with acute lymphoblastic leukemia  aged from 2 to 18 years suffering  from such dental diseases as generalized chronic catarrhal gingivitis, erosive-ulcerative and candidal stomatitis took part in the clinical study. All children under clinical study were divided into 2 groups - the main and comparison. Standard protocol treatment was used in the comparison group. Developed treatment-and-prophylactic complex was used in the main group. The children of the main group were prescribed developed treatment-and-prophylactic complex depending on the period of the disease: the first version of local treatment was used in the acute period and the relapse of the disease, the second - in the period of remission. The results of research have shown a stimulating effect of therapeutic and prophylactic measures on the natural antimicrobial system of mouth cavity protection, both in children of the main groups under study and in the comparison groups. Such a phenomenon should be considered as a positive process that contributes to the increase of resistance in periodontal tissues and mucous membrane epithelium of the mouth cavity

VALIDATION OF THE QUALITATIVE DETERMINATION OF HPLC METODS FOR SUCROSE AND PEG-2000-DSPE IN A LIPOSOMAL FORM OF THE PHOTOSENSITIZER LIPOPHTHALOCYAN

Objective: This study was undertaken with the aim of the validate the simple isocratic metods high-performance liquid chromatographic (HPLC) for the estimation of PEG-2000-DSPE and sucrose in liposomal medicinal formulations of the phthalocyanine photosensitizer Lipophthalocyan. Methods: HPLC quantification was carried out by using of YMC-Pack Polyamine II column. The mobile phase (for sucrose: acetonitrile: water: ethyl acetate in the ratio of 450: 200: 20; for PEG-2000-DSPE: water in the ratio 10: 90) was pumped at a flow rate of 1 ml/min. Following the guidelines of the International Conference on Harmonization (ICH), the methods was validated for various analytical parameters like specificity, linearity, detection limit, quantitative limit, correctness, and accuracy. Results: The obtained results of the analysis were validated statistically. The correlation coefficient for the linearity was 0.999292, for sucrose, and 0.997650 for PEG-2000-DSPE. The methods can be assessed as correct, as the results obtained are close to the true value and the confidence interval for both methods include 100%. The coefficients of variation in both methods in determining the accuracy were less than 3%. Conclusion: The proposed HPLC methods were validated according to the ICH guidelines and results and statistical parameters demonstrated that the developed methods are sensitive, precise, reliable and simple for the estimation of PEG-2000-DSPE and sucrose in Lipophthalocyan

Prospects for intranasal drug delivery systems with Ginkgo biloba in the treatment of cerebral circulatory disorders

Purpose: To analyze the range of currently available nasal medicines, and to study extant information on the use of Ginkgo biloba herbal complexes for the treatment of cerebral circulatory disorders of different etiologies. The study dwelt on the features and prospects of intranasal drug administration. Currently, intranasal administration is used primarily for the treatment of local symptoms. However, it has a much higher potential: the mucous membrane of the nasal cavity offers an opportunity for noninvasive treatment using systemic administration. Methods: The study involved the analysis of materials from information-retrieval systems, library databases, patent databases, and scientific information repositories such as e-Library. PubMed, Scopus, Google Scholar, as well as materials from the websites of manufacturers of herbal medicinal products and other herbal substances. Results: Herbal medicinal products have great potential in terms of intranasal administration. This is especially true of herbal medicines obtained through extraction of leaves of Ginkgo biloba, which have a broad spectrum of action, i.e., anti-aggregatory, venotonic, nootropic, anti-hypoxic, antioxidant, antiinflammatory, membrane-stabilizing, and capillary-protective effects. The range of Ginkgo biloba-based medicines calls for expansion, and this testifies to a good potential of these products in terms of further research and use. The analysis of literature and technical information showed the existence of a wide range of nasal medicines currently in use. However, only few drugs are used for the treatment of cerebrovascular diseases. Furthermore, there are no herbal medicines among these drugs, despite obvious advantages of herbal products such as ease of use, high bioavailability, and systemic action potential. Conclusion: The current status of research on nasal dosage forms of Ginkgo biloba herbal complexes warrants further development involving biopharmaceutical and pharmacological studies

Good Pharmacovigilance Practice in the United States and the European Union

The article presents the results of a comparative analysis of Goodpharmacovigilance practices (GVP), developed by experts of the regulatory bodiesof the European Union (EU) and the United States. It is shown that the EU GVP cover almost all possible aspects of pharmacovigilance. It is noted that the disadvantages of EU GVP are difficulties in the correct understanding and interpretation of certain definitions and processes, as well as the complexity of the implementation in practice of a number of provisions, mainly related to the organization of the quality management system, including audit and inspection. As the basis for development of the Russian Rules GVP is recommended to use the GVP E

Interchangeability of Essential Phospholipid Products

A significant share of the hepatoprotectors pharmaceutical market is represented by innovator and generic products containing essential phospholipids. One of the main issues in pharmacotherapy is confirmation of similarity between reference and generic products, which helps to assess their interchangeability. Therefore, it seems relevant to conduct comparative studies examining the products’ formulations (content of active pharmaceutical ingredients and excipients), dosage forms and routes of administration to identify characteristics that can affect interchangeability of essential phospholipid products. The objective of the study was to analyse interchangeability of generic and reference hepatoprotectors containing essential phospholipids. The nomenclature of essential phospholipids (oral (capsules), parenteral (solution for intravenous infusion and lyophilisate for solution for intravenous infusion), and topical (gel for cutaneous use) dosage forms) is given in accordance with the State Register of Medicinal Products, information storage and retrieval systems, and library databases (eLibrary, PubMed, CyberLeninka, ResearchGate).There was a significant difference in the content of phosphatidylcholine (29—93 %) in phospholipid substances produced by different manufacturers; minor differences were found in the quantitative composition of excipients in solutions, and significant differences were observed in the composition and quantities of excipients in capsules, which is most likely attributed to different production methods. The obtained data may be used to optimise pharmaceutical development and assess interchangeability of essential phospholipid products

Hadron-Hadron and cosmic-ray interactions at multi-TeV energies

The workshop on "Hadron-Hadron and Cosmic-Ray Interactions at multi-TeV Energies" held at the ECT centre (Trento) in Nov.-Dec. 2010 gathered together both theorists and experimentalists to discuss issues of the physics of high-energy hadronic interactions of common interest for the particle, nuclear and cosmic-ray communities. QCD results from collider experiments-mostly from the LHC but also from the Tevatron, RHIC and HERA-were discussed and compared to various hadronic Monte Carlo generators, aiming at an improvement of our theoretical understanding of soft, semi-hard and hard parton dynamics. The latest cosmic-ray results from various ground-based observatories were also presented with an emphasis on the phenomenological modeling of the first hadronic interactions of the extended air-showers generated in the Earth atmosphere. These mini-proceedings consist of an introduction and short summaries of the talks presented at the meeting

Combination of immune checkpoint inhibitors with radiation therapy in cancer: A hammer breaking the wall of resistance

Immuno-oncology is an emerging field in the treatment of oncological diseases, that is based on recruitment of the host immune system to attack the tumor. Radiation exposure may help to unlock the potential of the immune activating agents by enhancing the antigen release and presentation, attraction of immunocompetent cells to the inflammation site, and eliminating the tumor cells by phagocytosis, thereby leading to an overall enhancement of the immune response. Numerous preclinical studies in mouse models of glioma, murine melanoma, extracranial cancer, or colorectal cancer have contributed to determination of the optimal radiotherapy fractionation, as well as the radio- and immunotherapy sequencing strategies for maximizing the antitumor activity of the treatment regimen. At the same time, efficacy of combined radio- and immunotherapy has been actively investigated in clinical trials of metastatic melanoma, non-small-cell lung cancer and renal cell carcinoma. The present review summarizes the current advancements and challenges related to the aforementioned treatment approach

ON THE IMPACT OF DRUG NAMES AND LABELS ON THE RISK OF MEDICATION ERRORS

In this article authors analyze the influence of a label on drugpackage on the risk of medication errors and propose methods of their prevention.Analysis of the corresponding data published by regulators EMA and FDA hasprovided an opportunity to find examples of phonetic and graphic similaritieswith drugs identificatio

Comparative evaluation of recommendations for preclinical studies of transporter-mediated drug–drug interactions

Scientific relevance. Sound recommendations for preclinical studies of transporter- mediated pharmacokinetic interactions of medicinal products can help increase the likelihood of identifying potentially nephrotoxic and hepatotoxic medicinal products at the development and authorisation stages. However, overly strict requirements for the number of studies to be performed may lead to a significant increase in the cost of finished medicinal products.Aim. The aim was to compare regulatory documents on studying transporter-mediated drug–drug interactions (DDIs).Discussion. This review examines changes in regulatory requirements for studying DDIs in chronological order from the first guidelines that appeared in 1997. As exemplified in this article, the multiplicity of transporters and the lack of specific inhibitors pose significant challenges in assessing the role of a particular transporter in drug distribution and drug–drug interactions. This comparative review shows that extrapolating from in vitro transporter inhibition studies to in vivo pharmacokinetics can be misleading.Conclusions. A unified approach to studying transporter-mediated DDIs will increase the likelihood of identifying potentially toxic agents at the stage of new molecule screening. At the same time, it is advisable to limit the number of in vitro and in vivo transporter studies and recommend conducting these studies only for medicinal products with a narrow therapeutic index